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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00694564 |
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Date of registration:
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06/06/2008 |
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Primary sponsor: |
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Public title:
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Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
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Scientific title:
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A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00694564 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Jeannie Huang, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Diego |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 8 to 22 years old
- Diagnosed with RAP as verified by a physician, and having at least twice weekly
episodes of abdominal pain which cause the patient to withdraw from normal
activities.
- At least one month trial on a high fiber diet without resolution of abdominal pain.
- Ambulatory
Exclusion Criteria:
- Focal abdominal pain by history or physical exam, unless a negative (including
endoscopic) evaluation has been performed
- Current diagnosis of inflammatory bowel disease, pancreatitis (acute or recurrent),
peptic ulcer disease, gastrointestinal infection (unresolved), or ongoing
gastrointestinal inflammation.
- Current or recent (within the past year) pregnancy and/or current breastfeeding.
- Current diagnosis of nephropathy or genitourinary disease.
- Blood in stools or emesis (EXCEPTION: blood in the stool secondary to hemorrhoids is
not an exclusion criterion).
- Unintentional loss of over 10% body weight over the past 3 months or weight < 100%
ideal body weight.
- Recurrent fevers (T>100F) at least once a week or with abdominal pain episodes.
- Recurrent dehydration with abdominal pain episodes requiring intravenous rehydration.
- Current personal diagnosis of depression or report of suicidality, mania or bipolar
disorder.
- Family history of mania or bipolar disorder.
- Current use of opiates or other prescription pain medications and/or refusal to
remain off opiate/prescription pain medications during the study period.
- Currently receiving additional therapies besides diet for recurrent abdominal pain
and/or refusal to remain off such therapies during the study period, including but
not limited to anticholinergic medications, antidepressant medications, biofeedback
therapy, cognitive behavioral therapy.
- Hypersensitivity to SAM-e.
- Inability of child to provide assent and/or inability of parent/custodian to give
consent.
Age minimum:
8 Years
Age maximum:
22 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Abdominal Pain
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Intervention(s)
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Drug: S-adenosyl methionine
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Primary Outcome(s)
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Abdominal Pain Scale
[Time Frame: 0, 0.5, 1, 2 months]
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Secondary Outcome(s)
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Safety
[Time Frame: 0, 0.5, 1, 2]
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Secondary ID(s)
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IND 75,404
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UCSD060705
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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